PMA P180043S006
- Device
- therascreen FGFR RGQ RT-PCR Kit
- Applicant
- QIAGEN GmbH
- PMA number
- P180043
- Supplement
- S006
- Product code
- OWD
- Decision date
- 2023-12-22
- Classification
- Medical Genetics
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Changes to manufacturing process of device components
Current openFDA PMA Record#
- Device
- therascreen FGFR RGQ RT-PCR Kit
- Applicant
- QIAGEN GmbH
- PMA number
- P180043
- Supplement
- S006
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2023-12-22
- Decision code
- OK30
- Date received
- 2023-12-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to manufacturing process of device components